Glaxo Wellcome UK Ltd v Sandoz Ltd
| Jurisdiction | England & Wales |
| Judge | Lord Justice Arnold |
| Judgment Date | 04 October 2019 |
| Neutral Citation | [2019] EWHC 2545 (Ch) |
| Court | Chancery Division |
| Docket Number | Case No: HC-2015-005005 |
| Date | 04 October 2019 |
[2019] EWHC 2545 (Ch)
Lord Justice Arnold
Case No: HC-2015-005005
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS
INTELLECTUAL PROPERTY LIST (CHANCERY DIVISION)
Rolls Building
Fetter Lane, London, EC4A 1NL
Simon Malynicz QC, Tom Hickman QC, Stuart Baran and Stephanie Wickenden (instructed by Stephenson Harwood LLP) for the Claimants
Martin Howe QC, Iona Berkeley and Ashton Chantrielle (instructed by White and Case LLP) for the First to Fifth Defendants
Iain Purvis QC and Anna Edwards-Stuart (instructed by Bristows LLP) for the Sixth and Seventh Defendants
Hearing dates: 10–11, 15–19, 22, 24–26 July 2019
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
Contents
| Topic | Paragraphs |
| Introduction | 1–2 |
| The witnesses | 3–7 |
| Factual background | 8–155 |
| The licensing of medicines | 10–29 |
| Requirement for a marketing authorisation | 10–11 |
| Procedures for applying for marketing authorisations | 12–17 |
| Information that must accompany an application | 18–25 |
| Therapeutic equivalence of orally inhaled products | 26–28 |
| Requirement for brand name | 29 |
| Advertising of medicines | 30–33 |
| Prescribing | 34–41 |
| Prescribing generally | 34–36 |
| Branded vs. generic prescribing | 37–39 |
| “Off-label” prescribing | 40–41 |
| Dispensing | 42–43 |
| The NHS Drugs Tariff | 44–45 |
| Asthma and COPD | 46–51 |
| The Treatment of asthma and COPD with inhalers | 52–60 |
| Prescribing guidelines for asthma and COPD | 61–77 |
| NICE Guidelines | 62–65 |
| BTS/SIGN Guidelines | 66–67 |
| GINA guidance | 68–70 |
| GOLD guidance | 71–72 |
| Branded vs INN prescriptions | 73–74 |
| The importance of training and adherence | 75–76 |
| Downward titration in asthma | 77 |
| Local guidelines and formularies | 78–79 |
| The prescribing process for inhalers | 80–83 |
| Switching patients to different inhalers | 84 |
| CCG-Led switching | 85 |
| Dispensing guidelines and Standard Operating Procedures | 86–89 |
| The dispensing process in community pharmacies | 90 |
| Patient training and instruction | 91–92 |
| Dispensing errors | 93–94 |
| Ventolin | 95 |
| Serevent, Flixotide and Seretide | 96–100 |
| Marketing authorisations for Seretide Accuhaler | 101 |
| Sales of Seretide in the UK | 102–103 |
| The AirFluSal Forspiro product | 104–106 |
| AirFluSal MDI products | 107 |
| Marketing authorisations for AirFluSal Forspiro | 108–121 |
| Marketing of AirFluSal Forspiro in the UK | 122–126 |
| Branded versus generic prescribing for salmeterol/fluticasone combination inhalers | 127–128 |
| Sources of information for prescribers and pharmacists to check the licensing of an inhaler | 129–130 |
| Other salmeterol/fluticasone combination inhalers on the UK market | 131–137 |
| Other LABA/ICS combinations | 138 |
| Colour conventions for inhalers | 139–155 |
| The law | 156–189 |
| Basic principles | 156 |
| The relevant date | 157 |
| The need for deception | 158–162 |
| Misrepresentation as to trade origin | 163 |
| Misrepresentation by shape and/or colour | 164–169 |
| Recognition and association is not enough | 170–173 |
| Misrepresentation as to equivalence | 174–181 |
| The defendant's state of mind | 182 |
| Glaxo's case in outline | 190–191 |
| Goodwill: the distinctiveness of the colour purple | 192–194 |
| Distinctiveness as to trade origin amongst HCPs | 195 |
| Glaxo's marketing materials | 196–198 |
| Patient leaflets | 199 |
| The surveys | 200–246 |
| The 2015 surveys | 208–213 |
| The 2016 surveys | 214–217 |
| No surveys of patients or surveys concerning equivalence | 216 |
| The law | 218–219 |
| The Defendants' criticisms of the surveys | 220–246 |
| Guidelines (iii) and (vii) | 221–228 |
| Guideline (i) | 229–233 |
| Guideline (ii) | 234 |
| Guideline (iv) | 235–239 |
| Guideline (v) | 240–242 |
| Guideline (vi) | 243 |
| Conclusion on compliance with guidelines | 244 |
| Do the surveys demonstrative distinctiveness anyway? | 245–246 |
| Distinctiveness as to characteristics amongst HCPs | 247–248 |
| Distinctiveness as to trade origin amongst patients | 249–253 |
| Distinctiveness as to characteristics amongst patients | 254 |
| Facilitating switching | 255 – 259 |
| Misrepresentation to patients as trade origin | 260–266 |
| Misrepresentation to HCPs as to equivalence | 267–287 |
| Misrepresentation to patients as to equivalence | 288–289 |
| Recklessness | 290–307 |
| Joint liability of Aeropharm and Hexal | 308–315 |
| The law | 309 |
| Assessment | 310–315 |
| Result | 316 |
Introduction
This case is about the colour purple. The Claimants (“Glaxo”) have marketed a combination of salmeterol and fluticasone for the treatment of asthma and chronic obstructive pulmonary disease (“COPD”) under the trade mark Seretide in a proprietary dry powder inhaler (“DPI”) branded Accuhaler since 1999 and in a metered dose inhaler (“MDI”) branded Evohaler since 2000. Both the Seretide Accuhaler and the Seretide Evohaler are coloured two shades of purple (in the case of the Evohaler, the shades vary with the dose of fluticasone) and both are sold in packaging featuring a shade of purple (again, the shade varies with the dose of fluticasone). On 20 November 2015 the First, Second and Fifth Defendants (“Sandoz”) launched a branded generic competitor to the Seretide Accuhaler under the trade marks AirFluSal Forspiro. The Forspiro is a proprietary DPI designed by the Sixth and Seventh Defendants (“Vectura”). The AirFluSal Forspiro is largely coloured a shade of purple and is sold in packaging featuring a shade of purple. Glaxo claim that Sandoz have passed off the AirFluSal Forspiro as being (i) connected in the course of trade with Glaxo and/or (ii) equivalent to the Seretide Accuhaler through the get-up and packaging of the AirFluSal Forspiro. Although Glaxo's pleaded case also relies upon certain other aspects of the get-up and packaging, by the end of the trial the only feature Glaxo really relied upon was the use of purple. There is no dispute that Vectura are jointly liable for any passing off. Glaxo contend that the Third Defendant (“Aeropharm”) and the Fourth Defendant (“Hexal”), which are members of the same group of companies as Sandoz, are also jointly liable.
Although Glaxo commenced these proceedings as long ago as December 2015, the claim has had an unfortunate procedural history which meant that it only reached trial in July 2019. Regrettably, both sides have approached the matter as if it were a State Trial: there was a great deal of interlocutory skirmishing which continued right up to trial, a large volume of both documentary and witness evidence was produced and I received extensive written and oral submissions. It is not necessary for me to refer to all of this material in this judgment, and large parts of the documentary evidence turned out to be of little significance for reasons that will appear.
The witnesses
Even though a number of witnesses were dropped, I received evidence from a large number of factual witnesses: six employees or former employees of Glaxo; four solicitors employed by Glaxo's solicitors; six employees or former employees of Sandoz, Aeropharm and/or Hexal; one former employee of Vectura; four respiratory consultants; one junior hospital doctor; seven general practitioners (“GPs”); 13 pharmacists (two of whom were independent prescribers and two of whom were employed by Clinical Commissioning Groups, “CCGs”); one nurse independent prescriber; one physician associate; one regulatory affairs consultant; and one data analyst.
I do not consider it necessary to identify all of these witnesses or to discuss their evidence individually, although I shall mention some in context. I should, however, note two points.
The first is that, prior to the trial, Sandoz sought permission to adduce expert evidence from a respiratory consultant, a GP and a pharmacist. This application was successfully opposed by Glaxo, which contended that the relevant evidence could and should be given by factual witnesses giving so-called “trade” evidence (as to which, see in particular Fenty v Arcadia Group Brands Ltd [2013] EWHC 1945 (Ch), [2013] Bus LR 1165). Subsequently, the Defendants objected to the admissibility of substantial parts of the witness statements served by Glaxo on various grounds, but in particular that some of the statements were in substance expert evidence and that parts of others amounted to expressions of opinion, and in particular speculation by the witnesses as to the thought processes of other persons. At the pre-trial trial review I largely, although not entirely, upheld the Defendants' objections. This led to a cross-application by Glaxo to exclude parts of the witness statements served by the Defendants on similar grounds, which I partly upheld. At trial, by contrast, both sides repeatedly asked questions in cross-examination which were at least arguably inadmissible without objection from the other (although the Defendants did object to certain questions which were sought to be put by Glaxo to a couple of witnesses). In assessing the evidence, I have attempted to give weight to the witnesses' evidence of fact and not to their expressions of opinion.
The second point is that counsel for the Defendants pointed out that the witness statements of some of Glaxo's trade witnesses contained passages which cross-examination revealed did not accurately reflect their practices. As counsel accepted, this was probably not the witnesses' fault: they are busy...
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